Definitive sockets for fitting prostheses to residual limbs of amputees are made by various processes in accordance with prior art techniques. For example, numerous techniques have been developed that involve first, creating a negative mold of the residual limb, second, creating a positive mold from the negative mold, third, modifying the positive mold to provide relief for sensitive areas of the residuum, and fourth, forming the prosthesis socket using the modified positive mold. This technique involves numerous steps, and the negative and positive molds are typically created using Plaster-of-Paris. Some examples of this technique are embodied in U.S. Pat. No. 5,503,543, granted Apr. 2, 1996; and U.S. Pat. No. 6,991,444 granted Jan. 31, 2006, both to Laghi.
Another technique used to form prosthetic sockets is to reduce the steps in the above process by forming the socket directly on the residual limb without creating both a negative and a positive mold. This technique can be implemented in a variety of ways.
For example, U.S. Pat. No. 5,718,925, granted Feb. 15, 1998; U.S. Pat. No. 5,971,729, granted Oct. 26, 1999; U.S. Pat. No. 5,972,036, granted Oct. 26, 1999; and U.S. Pat. No. 6,416,703 granted Jul. 9, 2002, all to Kristinsson et al., and all herein incorporated by reference, all disclose a method of forming a definitive prostheses socket directly upon a residual limb. In the method, a web-like tubular braided carbon fiber sleeve that is pre-impregnated with a water curable resin is soaked in water and placed upon the residuum. The sleeve is pressure cast in a known manner using the ICECAST™ system made by Össur hf of Reykjavik, Iceland, and described in U.S. Pat. No. 5,885,509, granted Mar. 23, 1999 to Kristinsson, and herein incorporated by reference.
U.S. Pat. No. 5,980,576, granted Nov. 9, 1999 to Graf et al., discloses another method of forming a prosthetic socket directly on a residuum. A prosthetic liner is placed on the residuum, and pads are appropriately placed around the liner. Plastic wrap is applied around the liner to hold the pads in place. A knit fabric is then rolled over the liner, pads and plastic wrap. Finally, a resin impregnated fabric sock is soaked in water and applied over the knit fabric. The technician manually manipulates the fabric sock, and then plastic wrap and a resilient bandage can be applied over the fabric sock.
U.S. Pat. No. 6,156,071, granted Dec. 5, 2000 to Biedermann et al., discloses yet another method of forming a prosthetic socket on a residuum. A double walled tubular fabric is impregnated with a resin, such as polyurethane. The fabric is then dipped into activating water and pulled over the residuum, which may be covered with a prosthetic liner. The fabric may then be pressed against the residuum.
All of the above techniques for forming a mold or a prosthetic socket require access to water to activate the hardenable material used to form the prosthetic socket.
Another method of forming a prosthetic socket directly on the residuum is disclosed in U.S. Pat. No. 4,783,293, granted Nov. 8, 1988 to Wellershaus et al. The method involves placing a plastic sheet on the residuum and thermoforming the sheet by applying elevated temperatures to the sheet.
In yet another method of forming a prosthetic socket directly on the residuum, disclosed in U.S. Pat. No. 3,823,208 granted Jul. 9, 1974 to Asbelle et al., ultraviolet light is used to polymerize a fiberglass bandage on the residuum.
While many solutions for forming prosthetic socket exist, none of the prior art references disclose a kit and process of forming a prosthetic socket directly on the residuum, where a chamber is created around a web of material that is not pre-impregnated with a water hardenable resin or material, and a hardenable material is injected into the chamber.
The disclosed kit and process for forming a prosthetic socket overcome a number of disadvantages present in the prior art, such as reducing the complexity and steps required to form a prosthetic socket. The disclosed kit and process also allows for the formation of a prosthetic socket directly on a residuum without the use of water to activate a hardenable material.